COX-2 i's (cyclooxygenase-2 i's) a group of nonsteroidal antiinflammatory drugs that act by inhibiting cyclooxygenase-2 activity; they have fewer gastrointestinal side effects than other NSAIDs. Two members of the group are celecoxib and rofecoxib.

gastric acid pump inhibitor an agent that inhibits gastric acid secretion by blocking the action of H+,K+-ATPase at the secretory surface of gastric parietal cells; called also proton pump i.

HMG-CoA reductase i's a group of drugs that competitively inhibit the enzyme that catalyzes the rate-limiting step in cholesterol biosynthesis, and are used to lower plasma lipoprotein levels in the treatment of hyperlipoproteinemia. Called also statins.

plasminogen activator inhibitor (PAI) any of several regulators of the fibrinolytic system that act by binding to and inhibiting free plasminogen activator. Their concentration in plasma is normally low, but is altered in some disturbances of bodily hemostasis. PAI-1 is an important fast-reacting inhibitor of t-plasminogen activator and u-plasminogen activator. Its synthesis, activity, and release are highly regulated; elevated levels of it have been described in a number of disease states. PAI-2 is a normally minor inhibitor that greatly increases in concentration during pregnancy and in certain disorders. PAI-3 is protein C inhibitor.

protein C inhibitor the primary inhibitor of activated anticoagulant protein C; it is a glycoprotein of the serpin family of proteinase inhibitors and also inhibits several other proteins involved in coagulation (thrombin, kallikrein, and coagulation factors X and XI) and urokinase. Called also plasminogen activator inhibitor 3.

Indications

Action

Replaces C1 inhibitor which is deficient in patients with HAE. C1 inhibitor is necessary in preventing the chain of events which alter vascular permability resulting in life-threatening swelling in patients with HAE.

Therapeutic effects

Decreased frequency, intensity and duration of HAE attacks.

Pharmacokinetics

Absorption: IV administration results in complete bioavailibility.

Distribution: Unknown.

Metabolism and Excretion: Unknown.

Half-life: Single dose—56 hr.

Time/action profile

ROUTE

ONSET

PEAK

DURATION

IV

within 1 hr

12 hr

3–4 days

Contraindications/Precautions

Use Cautiously in: Patients with known risk of thrombotic events; Obstetric / Lactation: Use during pregnancy only if clearly needed; use cautiously during lactation; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

headache

Cardiovascular

thromboembolic events (life-threatening)

Dermatologic

rash

Miscellaneous

Hypersensitivity reactions including anaphylaxis

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Intravenous (Adults and adolescents) 1000 units every 3 or 4 days.

Availability

Powder for injections (requires reconstitution): 500 units/vial

Nursing implications

Nursing assessment

Assess for signs and symptoms of hypersensitivity reactions (hives, urticaria, tightness of the chest, wheezing, hypotension, anaphylaxis) during or after injection. Symptoms may be similar to HAE attacks; consider treatment methods carefully. If hypersensitivity occurs, discontinue infusion treat symptomatically. Epinephrine should be immediately available for treatment of acute severe hypersensitivity reaction.

Monitor patients with known risk factors for thrombotic events.

Potential Nursing Diagnoses

Ineffective airway clearance (Indications)

Implementation

Intravenous Administration

Intermittent Infusion: Diluent: Reconstitute each of 2 vials with 5 mL of Sterile Water for Injection by removing the protective covering from one end of the double-ended transfer needle and inserting exposed needle through the center of the diluent vial stopper. Remove protective covering from the other end of the double-ended transfer needle. Invert diluent vial over the upright and slightly angled C1 inhibitor vial; then rapidly insert the free end of the needle through the center of the C1 inhibitor vial stopper. Vaccuum in the vial will draw in the diluent. Do not use if there is no vacuum in the vial. Disconnect the two vials by removing the needle from the C1 inhibitor vial stopper and discard the diluent vial, along with the transfer needle directly into the sharps container. Gently swirl C1 inhibitor vial until all powder is completely dissolved. Solution is colorless to slightly blue; do not administer solutions that are discolored, turbid, or contain a precipitate. Insert the filter needle into the vial of reconstituted solution. Inject air into the vial and withdraw the reconstituted C1 inhibitor into the syringe. Repeat with a second vial to make complete dose. Concentration: 100 units/mL. Discard partially used vials. Attach a suitable needle or infusion set with winged adapter, and inject intravenously. Administer at room temperature within 3 hr of reconstitution. Do not freeze; protect solution from light.

Rate: Administer at an initial infusion rate 1 mL/min over 10 min. If tolerated, continue same as the maintenance infusion rate.

Y-Site Incompatibility: Do not mix with other materials.

Patient/Family Teaching

Inform patient that C1 inhibitor is made from human plasma and may contain infectious agents that can cause disease.

Instruct patient to notify health care professional immediately if signs and symptoms of allergic hypersensitivity reactions or thrombosis (new onset swelling and pain in limbs or abdomen, new onset chest pain, shortness of breath, loss of sensation or motor power, altered consciousness or speech) occur.

Advise female patients to notify if health care professional if pregnancy is planned or suspected or if breastfeeding.

Shire plc today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CINRYZE (C1 esterase inhibitor human ) for intravenous administration in subjects with Antibody Mediated Rejection (AMR) in renal transplant recipients.

The drug, dubbed Cinryze, is the only drug in Europe with the indication for the prevention of hereditary angioedema and was introduced on the US market several years ago, news agency Europa Press quoted the director of the Spanish unit of ViroPharma, Gilbert Credi, as saying today.

As per the deal terms, Halozyme may receive up to $83 million, commencing with an upfront payment of $9 million and total potential future milestone payments of $74 million dependent upon the achievement of clinical and regulatory targets, plus a 10 percent royalty on future sales of the combination of Cinryze with rHuPH20.

In Europe, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Cinryze for treatment and pre-procedural prevention of angioedema attacks in adults and adolescents with hereditary angioedema (HAE), and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of hereditary angioedema (HAE), who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment.

The CHMP also notes the relationship between Sanquin and ViroPharma, and that Sanquin's C1 inhibitor, Cetor, is approved in a limited number of member states for acute treatment which is one of the three indications recommended for Cinryze, as an outstanding issue that must be considered by the European Commission prior to approval of the Cinryze Marketing Authorization Application.

ViroPharma's key drugs include Cinryze for hereditary angioedema (HAE), Plenadren for the treatment of adrenal insufficiency (AI), Buccolam in Europe for the treatment of pediatric seizures, and Vancocin for the treatment of C.

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